Understanding and Mitigating Endpoint Bias in External Control Arms
About this episode
The episode discusses endpoint bias in external control arms and its implications for drug development.
External control arms are becoming increasingly important in drug development, but creating valid comparisons requires more than matching patient populations. In this episode, I speak with Ben Ackerman, Director of Real-World Biostatistics at GSK, about one of the most overlooked challenges in external control arm studies: endpoint bias. We discuss why differences in how outcomes are measured can influence study results, what researchers should consider when designing studies, and how the field is evolving to address these challenges. If you work with real-world evidence, causal inference, or innovative clinical trial designs, this episode offers valuable insights into improving the credibility and transparency of external control arm analyses.
People in this episode
Hosts: Alexander Schacht, Benjamin Piske
Guest: Ben Ackerman
Topics covered
- endpoint bias
- external control arms
- drug development
- real-world evidence
- clinical trial design
Keywords
- endpoint bias
- external control arms
- real-world biostatistics
- clinical trials
- study design
Mentioned in this episode
Organizations: GSK
More episodes of The Effective Statistician - in association with PSI
- The Future of Statistical Methodology in Drug Development
- Rethinking Programming Validation and Traceability in Clinical Trials
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